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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

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Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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CDRH Ushers in Changes to Device Submission System with Test Sandbox

The electronic system for medical device submissions to the US Food and Drug Administration’s (FDA) main gateway is set to go through a series of major coding changes, which were kicked off with a new test sandbox.

As the first step in a plan to enhance the Center for Devices and Radiological Health’s (CDRH) Electronic Medical Device Reporting (eMDR) system via harmonization with globally agreed upon adverse event reporting terminology, four sets of codes – Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code, and Manufacturer Evaluation Conclusion Code – will be affected by the first wave of scheduled updates.

Additional eMDR system updates are expected to be announced in upcoming months for the remaining non-harmonized codes, such as the Patient Problem Code and the Device Component Code.

The release of the new terminology and the planned changes to coding files in the eMDR system was first announced last November, “to give manufacturers time to update their internal systems to be able to use the new codes,” FDA spokesperson Stephanie Caccomo told Focus.

In preparation for the new system, FDA lets industry make changes “in a test environment so manufacturers can test their system changes,” she added.

Caccomo also noted that the changes are being made available in the test environment about a week ahead of the schedule announced last year.

“We let manufacturers know of this earlier availability to give them the most time possible to test their systems,” she said. “This announcement also reminds them of the date the changes will go into production.”

Testing of the updated code sets began on Tuesday, 6 March. The production deployment date – originally set for 6 April – has been delayed until 5 July to give device firms more time to “develop and validate the necessary changes to their adverse event complaint handling systems using the test eMDR system,” FDA said in a Thursday email.

But the need for prompt action is due to the codes that will be rejected by eSubmitter – the eMDR system’s software used for preparing submissions, which will receive simultaneous updates.

“Manufacturers must update their systems” because after the new production environment is deployed and the changes to the code sets come into effect, they “will not be able to submit reports using retired codes,” Caccomo said.

IMDRF Alignment

The eMDR system revamp is a result of FDA’s participation in the International Medical Device Regulators Forum (IMDRF). The IMDRF adverse event terminology working group “is iteratively producing new code sets, which are posted to the IMDRF documents repository as new annexes on a singular guideline document,” the agency explained.

The current eMDR system “is not configured to accept the IMDRF codes,” FDA said, but as “each new annex is published, FDA intends to update the corresponding FDA code set to harmonize with the new IMDRF code set; as a result, each IMDRF code will map to a single, distinct FDA code.”

Bernard Jee, program manager at Pilgrim Quality Solutions, a software company that previously collaborated in the development of eSubmitter, told Focus a total of 35 codes will be deactivated once the new production environment is deployed, easing the burden with the submission process.

According to Jee, harmonization will lead to a reduced number of submissions requiring FDA review, and less codes for companies to keep track of across different regulatory bodies. Smaller firms with resource constraints may find the updates to be particularly beneficial, though early preparation will be key.

CDRH plans to eventually harmonize all remaining codes in the eMDR system with IMDRF adverse event terminology and retired codes will be removed. FDA’s eMDR team intends to update the agency guidance on the new sets of codes, terms and definitions throughout the harmonization process.

Jee advises downloading the new product codes and partaking in the testing of their adverse event systems to ensure preparedness prior to production deployment dates to avoid any issues with FDA.

He also noted that the US is not unique in these code harmonization efforts as similar updates are being made to the system used by the UK’s Medicines and Healthcare products Regulatory Agency and its customers.

The agency began rolling out a new version of its online service for medical device submissions late last year with a new requirement to begin using the IMDRF-recommended Global Medical Device Nomenclature, among other changes, as it moves to implement the European regulations on medical devices and in vitro diagnostics, though it remains to be seen how these will be affected post-Brexit.